The following data is part of a premarket notification filed by Vasonova Inc. with the FDA for Vascular Positioning System Tm (vps Tm System) Stylet.
| Device ID | K103255 |
| 510k Number | K103255 |
| Device Name: | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park, CA 94025 |
| Contact | Kim Tompkins, Rn, Mba |
| Correspondent | Kim Tompkins, Rn, Mba VASONOVA INC. 155 JEFFERSON DRIVE SUITE 100 Menlo Park, CA 94025 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-03 |
| Decision Date | 2011-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902111471 | K103255 | 000 |
| 20801902219064 | K103255 | 000 |
| 20801902211884 | K103255 | 000 |
| 20801902211334 | K103255 | 000 |
| 20801902211341 | K103255 | 000 |
| 20801902201977 | K103255 | 000 |
| 50801902129814 | K103255 | 000 |
| 40801902124201 | K103255 | 000 |
| 40801902117616 | K103255 | 000 |
| 40801902124232 | K103255 | 000 |
| 20801902160939 | K103255 | 000 |
| 20801902160946 | K103255 | 000 |
| 20801902160038 | K103255 | 000 |
| 20801902134992 | K103255 | 000 |
| 20801902145776 | K103255 | 000 |
| 30801902089831 | K103255 | 000 |
| 30801902111464 | K103255 | 000 |
| 20801902219002 | K103255 | 000 |